How a Class III Device Company Passed Their ISO 13485:2016 Re-Certification Audit with a Modern QMS and Industry Expertise

Who is MediBeacon?

MediBeacon is a Medical Technology company that specializes in the advancement of fluorescent tracer agents and transdermal measurement. The company has multiple combination products (which include both a medical device and a diagnostic agent) in various stages of clinical development. 

The MediBeacon® Transdermal GFR Measurement System (TGFR) is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function.  

The company is focused on bringing transformational technology into medical practice. Their goal is to deliver products that can have a profoundly positive impact on both the quality and cost of patient care. 

The Challenge: MediBeacon needed a flexible yet organized QMS 

MediBeacon’s TGFR is a class III combination device, which means it must go through the FDA Premarket Approval (PMA) pathway. 

In addition, MediBeacon had contracted with multiple device development and manufacturing organizations. The drug component of their device must be in compliance with 21 CFR Part 4 - Regulation of Combination Products.

“We have a combination product, so we had to make sure we were handling the design and development of the device as well as that of the drug. All components had to be addressed and then pulled together within the context of the complete system,” said Laura Vitale, VP of Quality at MediBeacon. 

MediBeacon quickly realized that a paper-based QMS or a generic software solution wasn’t going to be sufficient for them to successfully navigate the required regulatory and management hurdles. 

“We started with a paper-based QMS, but this was really difficult to maintain. This methodology would have made creation of a strong design history file, device master record and traceability matrix an almost insurmountable challenge.” 

So, they turned to Greenlight Guru. 

The Solution: A MedTech-specific QMS and the Guru Edge

MediBeacon knew they couldn’t keep using a paper-based solution for their QMS. The Company considered a range of eQMS solutions. In the end, it came down to one thing.

“The biggest reason we chose Greenlight Guru was that their eQMS is designed for device manufacturers and developers. It is very specific to our needs”, said Vitale. “So many of the other systems we looked at try to be everything to everybody. The result can be that you’re not really getting the best solution for a medical device company.” 

An intuitive user experience, ISO 13485 compliance, and the validation package Greenlight offers rounded out the reasons MediBeacon chose Greenlight Guru. 

What happened after they purchased Greenlight Guru left a real impression on the team at MediBeacon. The Customer Success team at Greenlight, affectionately known as “The Gurus”, were there for them at every step.

“The Gurus have been invaluable,” according to Vitale. “The team is very ‘can-do’. They are always ready to help us. It’s not easy moving away from a paper-based system. The Gurus helped us bring everything into the system in a way that facilitated editing and the maintenance of up-to-date documents.”

The Results: A clean ISO 13485 re-certification and the team gets its time back

In Greenlight Guru, MediBeacon found a dedicated partner who helped them onboard efficiently, save valuable time, and pass an ISO 13485 recertification.

4x faster time-to-value experience with the Guru Edge 

Migrating a paper-based QMS to an entirely new system doesn’t happen overnight. However, it does not have to be a painful and drawn-out experience. 

Greenlight Guru’s onboarding process helped MediBeacon get started using the software confidently while also being efficient. The experience was even more enriching for the team with the Gurus there every step of the way. 

3 months saved each year 

MediBeacon has been using Greenlight Guru for about two and a half years. Vitale can only roughly estimate just how much time has been saved over that period. 

“Having Greenlight has saved at least 20% of my time over the course of a year. It’s so easy to reference things in Greenlight. I am in the system every single day.”

Flawless ISO 13485 re-certification

The intuitive user experience wasn’t the only time saver. When it came time for MediBeacon’s ISO 13485 re-certification audit (an intense, multi-day affair), they were ready.

“We came away with zero deficiencies. Our auditor told us, ‘Everything I usually offer as opportunities for improvement, you’re already doing, and the system looks excellent.’”

“That’s a huge element in making sure we’ll be able to get our products to market,” added Vitale. 

What’s Next for MediBeacon?

Of course, there’s much more to come. Vitale noted there are several more products in the works and the team is looking forward to ensuring effective development of their entire platform of products. 

This time around, they get to start with Greenlight Guru. The team plans to continue to use Greenlight Guru’s Design Control and Risk Management workspaces for their design and development.